Clinical Predictors of Early Trial Discontinuation for Patients Participating in Phase I Clinical Trials in Oncology.

ABSTRACT: Despite stringent eligibility criteria for trial participation, early discontinuation often occurs in phase I trials. To better identify patients unlikely to benefit from phase I trials, we investigated predictors for early trial discontinuation. Data from 415 patients with solid tumors who participated in 66 trials were pooled for the current analysis. Early trial discontinuation was defined as (i) trial discontinuation within 28 days after start of treatment or (ii) discontinuation before administration of the first dosage in eligible patients. Multilevel logistic regression analyses were conducted to identify predictors for early trial discontinuation. Eighty-two participants (20%) demonstrated early trial discontinuation. Baseline sodium level below the lower limit of normal (OR = 2.95

SUBMITTER: Douma JAJ 

PROVIDER: S-EPMC8151105 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature